PRECISION PRESS TACK / INTRADERM, SEVEN STAR AND ACUPUNCTURE NEEDLES; ALPHA AND FINE POINT ACUPUNCTURE NEEDLES

K061517 · Prime Herbs Corporation · MQX · Nov 22, 2006 · General Hospital

Device Facts

• Record ID: K061517
• Device Name: PRECISION PRESS TACK / INTRADERM, SEVEN STAR AND ACUPUNCTURE NEEDLES; ALPHA AND FINE POINT ACUPUNCTURE NEEDLES
• Applicant: Prime Herbs Corporation
• Product Code: MQX · General Hospital
• Decision Date: Nov 22, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5580
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

To pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.

Device Story

Acupuncture needles (Precision Press Tack, Intraderm, Seven Star, Präzision, Alpha, Fine Point, Chi, Zen) are sterile, single-use devices. Used by qualified acupuncture practitioners in clinical settings to pierce skin for acupuncture therapy. Devices function as manual instruments; no electronic or automated components. Benefit derived from facilitating standard acupuncture practice.

Clinical Evidence

No clinical data. Substantial equivalence based on design, material, sterility, and biocompatibility specifications meeting general criteria for single-use acupuncture needles.

Technological Characteristics

Sterile, single-use acupuncture needles. Materials and design meet general specifications for acupuncture needles. No energy source, connectivity, or software.

Indications for Use

Indicated for use by qualified acupuncture practitioners to pierce the skin for the practice of acupuncture.

Regulatory Classification

Identification

An acupuncture needle is a device intended to pierce the skin in the practice of acupuncture. The device consists of a solid, stainless steel needle. The device may have a handle attached to the needle to facilitate the delivery of acupuncture treatment.

Special Controls

*Classification.* Class II (special controls). The device, when it is an acupuncture point locator or a single use acupuncture needle, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9. Acupuncture needles must comply with the following special controls:(1) Labeling for single use only and conformance to the requirements for prescription devices set out in 21 CFR 801.109, (2) Device material biocompatibility, and (3) Device sterility.

Submission Summary (Full Text)

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K061517

October 10, 2006

## PRE-MARKET NOTIFICATION 510 (K) SUMMARY

(As Required by 21 CFR 807.92)

Prime Herbs Co., 754 San Aleso Avenue Sunnyvale, CA 94085 Phone: [phone] Genevieve Hsia

NOV 2 2 2006

Device Name: Precision Press Tack / Intraderm Needle, Precision Seven Star Needle, Präzision Acupuncture Needle, Alpha Acupuncture Needle, Fine Point Acupuncture Needle, Chi Acupuncture Needle and Zen Acupuncture Needle Common Device Name: Acupuncture Needle, Signal Use Product Code: MQX Medical Specialty: General Hospital Device Class: II

Precision Press Tack / Intraderm Needles, Precision Seven Star Needles, Präzision I receision 11035 Tach / Alpha Acupuncture Needles, Fine Point Acupuncture Needles, Chi Acupuncture Needles, Inc. Zen Acupuncture Needles are defined as prescription devices intended to reapanetate rebates are tice of acupuncture by qualified practitioners of acupuncture as determined by the States.

FDA had issued 510(K)s to 47 different signal use acupuncture Needless brand and them have I DA had issued 9 ro(11)3 wire in the United States since 1996. We had searched Federal Consumer Information Center web site http://www.pueblo.gsa.gov and U.S. Consumer Product Safety Commission web site http://www.cpsc.gov and found no serious or We threatening accidents involving acupuncture Needless.

Precision Press Tack / Intraderm Needles, Precision Seven Star Needles, Präzision Acupuncture 1 (CUSTO) Fress Fack - The Point Acupuncture Needles, Chi Acupuncture Needles and Needes, Alpha Acupanedare sterile, single use only. The design, material used, sterility and hiocompatibility of this acupuncture Needles meet the general specifications and criteria for an single use acupuncture Needles and is effective for the practice of acupuncture.

In conclusion, based on the information provided with this 510(K) Notification, the Precision Press In conclusion, based on the Precision Seven Star Needles, Präzision Acupuncture Needles, Alpha Tack / Intraderin Necdles, Freehslon Soven Star Fronter Needles and Zen Acupuncture Acupunciale Necutes, I he Follo Reapanetane Press Tack / Intraderm Needles, Nectiles meet the or nerial 10. 910(1) issort Acupuncture Needles, Alpha Acupuncture Needles, Fine Point I recision Devell Star Procures Needles and Zen Acupuncture Needles are equivalent to other Acupuncture Needless which are currently being sold through interstate commerce.

Genevieve Hsia, President

Date

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and wings. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters.

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Genevieve Hsia President Prime Herbs Corporation 754 San Aleso Avenue Sunnyvale, California 94085

NOV 2 2 2006

Re: K061517

Trade/Device Name: Fine Point Acupuncture Needle, Alpha Acupuncture Needle, Prazision Acupuncture Needle, Zen Acupuncture Needle, Chi Acupuncture Needle, Precision Press Tack, Precision Intradermal Needle and Seven Star Needle Regulation Number: 880.5580 Regulation Name: Acupuncture Needle Regulatory Class: II Product Code: MOX Dated: October 19, 2006 Received: October 19, 2006

Dear Ms. Hsia:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Hsia

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Soutte y. Michael Dms.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K061517

- Device Name: Fine Point Acupuncture Needle, Alpha Acupuncture Needle, Prazision Acupuncture Needle, Zen Acupuncture Needle, Chi Acupuncture Needle, Precision Press Tack, Precision Intradermal Needle, & Seven Star Needle
- Indications For Use: To pierce the skin in the practice of acupuncture by qualified practitioners of acupuncture as determined by the States.

Prescription Use X AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
Suytle Y. Michem MD
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utatiology, General Hospital,
won Contol, Denial Devices
K 061517